GERAP's Epidemiological Survey on Perioperative Hypersensitivity Reactions

Hypersensitivity, Drug Clinical Trial

— SERAP  

Official title:

Epidemiological Survey on Perioperative Hypersensitivity Reactions in France by the GERAP Network (Groupe d'étude Des réactions Anaphylactiques périopératoires)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04654923
• Other study ID #: 8038
• Status: Recruiting
• Start date: November 12, 2020
• Est. completion date: May 12, 2031

Study information

• Verified date: April 2023
• Source: University Hospital, Strasbourg, France
• Contact: Paul-Michel MERTES, MD, PhD
• Phone: 33 3 69 55 04 44
• Email: paul-michel.mertes[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Perioperative hypersensitivity reactions are still associated with significant morbidity and mortality despite early recognition and use of epinephrine. The epidemiology of these reactions evolves over time and changes with clinical practice. The main objective is to study the epidemiology of these reactions over a 10-year period, including patient phenotype, reaction phenotype and outcome of the allergic work-up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: May 12, 2031
• Est. primary completion date: May 12, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years and older

Eligibility

Inclusion Criteria:

• Minor and major subject
• Subject having experienced a perioperative hypersensitivity reaction between January the 1st 2017 and December the 31st 2027.
• Referred for an allegro-anesthetic workup
• Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion Criteria:

• Subject having expressed opposition to participating in the study
• Inability to provide the subject with research information
• Subject under guardianship or guardianship
• Subject under safeguard of justice

Related Conditions & MeSH terms

• Drug Hypersensitivity
• Hypersensitivity
• Hypersensitivity, Drug

Locations

Country	Name	City	State
France	Service d'anesthésie-réanimation - CHU de Strasbourg - France	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retrospective analysis of incidence of all perioperative hypersensitivity reactions referred in an allegro-anesthetic		Outcome is analysed every 2 years over a 10 years period